A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Female patients aged ≥ 18 but ≤ 75 years
• Histologically confirmed to be HER2-positive invasive breast cancer
• Treatment-naive patients with stage II-III
• Eastern Cooperative Oncology Group (ECOG) score 0-1
• Good level of organ function
Locations
Other Locations
China
Shengjing Hospital affiliated to China Medical University
RECRUITING
Shenyang
Contact Information
Primary
Nan Niu, MD
niunannancy@163.com
86-18940256668
Time Frame
Start Date: 2023-03-16
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 65
Treatments
Experimental: SHR-A1811+Pyrotinib
Experimental: SHR-A1811
Related Therapeutic Areas
Sponsors
Leads: Shengjing Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.